Keralyt

Product NDC: 11086-043
11-digit product format: 110860043
Labeler code: 11086
Product ID: 11086-043_f214aff3-7a3a-ce40-e053-2995a90a8abb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: salicylic acid
Dosage form: SHAMPOO
Route: TOPICAL
Labeler: Summers Laboratories Inc
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2009-11-01
Marketing end: 0000-00-00
Substance: SALICYLIC ACID
Active strength: 6 g/92.6mL
NDC exclude flag: No
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	11086-043		I	Inactivated by FDA		2026-10-12
excluded package	package	11086-043	11086-043-06	I	Inactivated by FDA		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	11086-043-06	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	11086-043-06	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	11086-043-06	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	11086-043-06	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	11086-043-06	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	11086-043-06	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	11086-043-06	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	11086-043-06	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	11086-043-06	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
11086-043-06	2025-01-30	C162847	48780-1	2cef2736-88d3-d83d-e063-dadaa90ab31f	SUMMERS LABS (as PLD) - Keralyt Shampoo (11086-043)
11086-043-06	2025-01-30	C162847	48780-1	2cef2736-88d3-d83d-e063-dadaa90ab31f	Keralyt 6 Shampoo (11086-043)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
11086-043-06	Keralyt	160 mL in 1 BOTTLE, WITH APPLICATOR	SHAMPOO	1 mL	6 g in 92.6mL	16
11086-043-06	Keralyt	160 mL in 1 BOTTLE, WITH APPLICATOR	SHAMPOO	160		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11086-043-06	ML - Milliliter	11086-043	4515a83d-c4bf-48ae-8fac-488bda43f855	1	2021-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	KERALYT (SALICYLIC ACID) KIT [SUMMERS LABORATORIES INC]	10
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	KERALYT (SALICYLIC ACID) KIT [SUMMERS LABORATORIES INC]	10
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	KERALYT (SALICYLIC ACID) SHAMPOO [SUMMERS LABORATORIES INC]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	KERALYT (SALICYLIC ACID) SHAMPOO [SUMMERS LABORATORIES INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11086-043	KERALYT (SALICYLIC ACID) KIT [SUMMERS LABORATORIES INC]	16	Legacy NDC	20231010_79bff5e0-bccb-11de-b462-0002a5d5c51b.zip
11086-043	KERALYT (SALICYLIC ACID) SHAMPOO [SUMMERS LABORATORIES INC]	6	Legacy NDC, 1 package rows	20231010_55632908-8757-11de-8a39-0800200c9a66.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
O414PZ4LPZ	SALICYLIC ACID	69-72-7	SALICYLIC ACID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
883501	{1 (60000 MG) (salicylic acid 0.06 MG/MG Topical Gel [Keralyt]) / 1 (160 ML) (salicylic acid 60 MG/ML Medicated Shampoo [Keralyt]) } Pack [Keralyt Scalp]	BPCK	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
866892	{1 (60000 MG) (salicylic acid 0.06 MG/MG Topical Gel) / 1 (160 ML) (salicylic acid 60 MG/ML Medicated Shampoo) } Pack	GPCK	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
999618	Keralyt 6 % Medicated Shampoo	PSN	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
883501	Keralyt 6 % Scalp Complete Kit	PSN	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
212332	Keralyt 6 % Topical Gel	PSN	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
667904	salicylic acid 6 % Medicated Shampoo	PSN	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
866892	salicylic acid 6 % Medicated Shampoo (160 ML) / salicylic acid 6 % Topical Gel (60000 MG) Pack	PSN	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
312893	salicylic acid 6 % Topical Gel	PSN	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
212332	salicylic acid 0.06 MG/MG Topical Gel [Keralyt]	SBD	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
999618	salicylic acid 60 MG/ML Medicated Shampoo [Keralyt]	SBD	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
312893	salicylic acid 0.06 MG/MG Topical Gel	SCD	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
667904	salicylic acid 60 MG/ML Medicated Shampoo	SCD	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
866892	{1 (160 ML Salicylic Acid 6 % Medicated Shampoo) / 1 (60000 MG Salicylic Acid 6 % Topical Gel) } Pack	SY	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
212332	Keralyt 0.06 MG/MG Topical Gel	SY	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
999618	Keralyt 6 % Medicated Shampoo	SY	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
883501	Keralyt 6 % Scalp Complete Kit	SY	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
212332	Keralyt 6 % Topical Gel	SY	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
999618	Keralyt 60 MG/ML Medicated Shampoo	SY	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
667904	salicylic acid 6 % Medicated Shampoo	SY	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
312893	salicylic acid 6 % Topical Gel	SY	79bff5e0-bccb-11de-b462-0002a5d5c51b	16
999618	Keralyt 6 % Medicated Shampoo	PSN	55632908-8757-11de-8a39-0800200c9a66	6
667904	salicylic acid 6 % Medicated Shampoo	PSN	55632908-8757-11de-8a39-0800200c9a66	6
999618	salicylic acid 60 MG/ML Medicated Shampoo [Keralyt]	SBD	55632908-8757-11de-8a39-0800200c9a66	6
667904	salicylic acid 60 MG/ML Medicated Shampoo	SCD	55632908-8757-11de-8a39-0800200c9a66	6
999618	Keralyt 6 % Medicated Shampoo	SY	55632908-8757-11de-8a39-0800200c9a66	6
999618	Keralyt 60 MG/ML Medicated Shampoo	SY	55632908-8757-11de-8a39-0800200c9a66	6
667904	salicylic acid 6 % Medicated Shampoo	SY	55632908-8757-11de-8a39-0800200c9a66	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11086-043-06	11086004306	160 mL in 1 BOTTLE, WITH APPLICATOR (11086-043-06)	160 ml	2009-11-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Keralyt 6 Shampoo (11086-043)	Summers Laboratories Inc	2026-10-09	HUMAN PRESCRIPTION DRUG LABEL	7
SUMMERS LABS (as PLD) - KERALYT KIT (11086-047)	SUMMERS LABORATORIES INC	2023-10-09	HUMAN PRESCRIPTION DRUG LABEL	16